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FDA 510(k) Application Details - K033746
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K033746
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
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Contact
REY LIBROJO
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Regulation Number
878.4493
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Classification Product Code
GAM
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Date Received
12/01/2003
Decision Date
12/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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